Responsibilities:

• Providing clinical leadership and strategic medical input for all clinical deliverables in Rapport’s lead program, RAP-219, related to Bipolar Disorder
• Driving execution the assigned clinical program and/or clinical trial in partnership with clinical operations
• Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
• Ensure that scientific rigor and innovation is at the forefront our Rapport’s clinical development strategy
• Manage engagements with external organizations, key opinion leaders, and advisors
• Supporting the Head of Clinical Development by providing medical input into Clinical development strategy and protocol reviews
• Work closely with functional partners (Clinical Operations, Data Management, Biostatistics, Regulatory. Medical Affairs) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocols
• Establishes strong collaborations with study investigators, outside medical experts and represent Rapport during investigator meetings and advisory boards.
• Serve as the medical monitor for assigned studies including design, execution and interpretation of study data.

Requirements:

• MD or equivalent medical degree is required
• Minimum of 5 years of experience working in the biotech/pharmaceutical industry in clinical research or drug development or as study investigator
• Preferred advanced knowledge and clinical training and/or drug development experience in Neuropsychiatry
• Proven clinical development strategist with hands-on experience with designing, implementing, and conducting clinical trials in psychiatry, Phase 2a – Phase 3.
• Working knowledge of Bipolar Disorder is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
• Demonstrated ability to establish effective scientific partnerships with key stakeholders
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Experience authoring regulatory documents, specifically exposure to the IND/NDA/BLA approval process
• Ability to communicate and work both independently and collaboratively with colleagues across disciplines
• Excellent oral presentation skills.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Comfortable in a fast-paced small startup environment with minimal direction and able to adjust workload based upon changing priorities.